This trial is active, not recruiting.

Conditions neoplasms, neoplasm metastasis, melanoma, carcinoma, non-small-cell lung, colorectal neoplasms
Treatment ly3009120 capsule
Phase phase 1
Target RAF
Sponsor Eli Lilly and Company
Start date November 2013
End date July 2017
Trial size 50 participants
Trial identifier NCT02014116, 13873, I6X-MC-JBDA


The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
LY3009120 in escalating dose cohorts given orally BID (twice daily) every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
ly3009120 capsule
Administered orally.

Primary Outcomes

Maximum Tolerated Dose (MTD) of LY3009120
time frame: Cycle 1 (28 Days)

Secondary Outcomes

Number of Participants with Tumor Response
time frame: Baseline through study completion (estimated as 37 months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120
time frame: Cycle 1: Predose up to 12 hours postdose (Cycle = 28 Days)
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3009120
time frame: Cycle 1: Predose up to 12 hours postdose (Cycle = 28 Days)

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Advanced or metastatic cancer - Other available therapies have failed to cure the cancer - The cancer that has no proven effective therapy - The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) - Able to swallow capsules Exclusion Criteria: - Have active cancer in the brain or spinal cord - Have an active infection of any kind (fungal, viral, or bacterial) - Have a cancer of the blood - Are pregnant or breastfeeding - Have some types of eye problems or impairments

Additional Information

Official title A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.